ExThera Medical: Will Its Seraph™ Device Eliminate Bacteremia and Prevent Sepsis at Point-of-Care?

The first start-up by Bob Ward—The Polymer Technology Group (PTG)—earned a 555X return for investors upon its sale in 2008 to DSM, the global life sciences and materials company. Now, Bob Ward’s swinging away at another potential homerun: ExThera Medical, a Berkeley, California-based company, with its scientific origins at the Karolinska Institute in Stockholm, Sweden.

ExThera Medical (www.extheramedical.com) is developing — and hopes to soon commercialize — an innovative medical device, Seraph™ Microbind™ Affinity Blood Filter (‘Seraph), that may capture and remove a wide range of pathogens and disease-causing agents from circulating blood. These agents can cause bacteremia, extreme inflammation, sepsis, septic shock and multiple organ failure.

Using its patented ‘Seraph’ technology, ExThera intends to provide the critical care medical community with an important new therapy that quickly and safely reduces the blood’s bacterial and/or viral load.

At the same time it removes pathogens, ‘Seraph’ can also reduce circulating levels of many of the factors that initiate a patient’s extreme inflammatory response, including bacterial toxins, pro-inflammatory cytokines, harmful proteins, and other virulence factors.

Bottom line? ExThera’s management believes that their Seraph device is unique in its broad-spectrum ability to safely remove harmful substances from the blood; no other single technology is known to sweep all of these agents from the blood of bacteremic and septic patients in a single course of treatment.

ExThera management also says the company is on the cusp of commercialization outside of the U.S. in an enormous market in dire need of its unique technology.

Management says that ExThera’s ‘biomimetic’ Seraph™ device is based on the natural biologic process of binding used by pathogens to invade the body. By attaching to specific receptor sites on the surface of cells inside blood vessels and major organs, pathogens (viruses, bacteria and parasites) subvert our immune system. Seraph™ uses similar binding sites to remove these same pathogens and their toxins from the circulating blood of infected patients.  Seraph may also be used to purify banked blood during donation or transfusion.

Seraph™ (Selective Removal by Apheresis) is based on an often-overlooked mechanism of action — the unique binding capacity of immobilized, naturally occurring heparin molecules. Disease-causing microorganisms use cell-surface glycoconjugates — such as heparan sulfates — as receptor sites for cell attachment, to facilitate invasion and colonization of tissue. Heparin, a pharmaceutical analog of heparan sulfate, can be used as a diversion for these pathogens and undesired cytokines when it is covalently bound and immobilized using end-point attachment in a proprietary process. When a patient’s blood is passed through a Seraph column, pathogens and cytokines are diverted from the bloodstream to the bound heparin, are captured, and removed when the device is disconnected from the patient.  As with other blood-contacting medical devices using surface-bonded heparin for anti-coagulation, it is reasonable to expect that Seraph™ will be inherently safe.

ExThera Medical is investigating the clinical impact of its proprietary and patented immobilized heparin technology to bind viruses, antibiotic-resistant bacteria, exotoxins, parasites and cytokines in blood, while developing therapeutic products to treat patients in the clinic, and devices that purify banked blood prophylactically.

“Use of heparin in this manner represents a novel way of delivering its therapeutic properties that avoids exposing patients to the risk of thrombocytopenia and hemorrhage caused by systemic administration,” said Mr. Ward. “Seraph™ has been engineered for very low pressure drop and blood flow rates up to 300 mL/minute, offering speed and efficiency. Seraph is unlike other technologies that attempt to capture chemical messengers using ‘size exclusion.’ (Indiscriminate removal of proteins based on molecular size may remove all proteins below a certain molecular weight, including ‘good’ proteins.) Instead, Seraph™ uses the activity of naturally-occurring biomolecules to achieve results, through a specific binding process.”

Proof-of-concept studies of Seraph™, published in peer-reviewed journals, demonstrate that pathogens and inflammatory cytokines are removed in high-yield from human blood.

ExThera Medical management will be presenting at OneMedForum in San Francisco January 7-9, 2013.

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